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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

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MENTOR TEXAS MENTOR SMOOTH ROUND MODERATE PROFILE PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE Back to Search Results
Model Number 3501670
Device Problem Device Contamination with Chemical or Other Material
Event Date 10/05/2017
Event Type  Malfunction  
Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made. As such, the investigation will be closed. If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate. The device history record (dhr) was reviewed and no anomalies were found related to this complaint. In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures. Manufacturer's ref. No: (b)(4).

 
Event Description

It was reported by a physician's office that a mentor smooth round moderate profile saline implant (catalog #3501670, serial # (b)(4)) had an out of box issue. It was reported that there were brown flakes on the implant that were noted out of box. Per the customer, the implant did not come into contact with any patient. No patient consequence was reported. The customer requested that no further contact be initiated for follow up attempts. Therefore, no additional information is available.

 
Manufacturer Narrative

On 10/27/2017, the mentor failure analysis lab received the device for evaluation. The analysis has begun but is not completed at this time. When the investigational analysis has been completed, a supplemental 3500a report will be submitted. (b)(4).

 
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Brand NameMENTOR SMOOTH ROUND MODERATE PROFILE
Type of DevicePROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
Manufacturer (Section D)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer (Section G)
MENTOR TEXAS
3041 skyway circle north
irving TX 75038
Manufacturer Contact
joaquin kurz
3041 skyway circle north
irving , TX 75038
949789-383
MDR Report Key6975001
Report Number1645337-2017-00122
Device Sequence Number1
Product CodeFWM
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/24/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number3501670
Device Catalogue Number3501670
Device LOT Number7483717
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/27/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2017
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/17/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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